Senior GMP QA & Compliance Specialist

Alcami Corporation; South Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Alcami Corporation is seeking a Senior Quality Assurance Specialist to drive GMP compliance and partner with cross-functional teams in developing SOPs and quality documents. The role emphasizes mentoring Operations personnel and supporting regulatory inspections.

The position requires hands-on quality review, document control, audits, and maintaining quality databases to ensure readiness for inspections and ongoing regulatory compliance.

Qualifications

• BSc/Bachelor’s degree in Chemistry, Biology or related field with GMP experience.
• Master’s degree in related field is acceptable.
• Experience in aseptic parenteral manufacturing is required.
• Visual inspection qualification (20/20 vision) is preferred.

Responsibilities

• Performs quality review and approval of documents, data, protocols, and reports.
• Performs GMP document creation and issuance (batch records, logbooks, forms).
• Performs visual inspection of parenteral product (requires qualification).
• Conducts internal quality audits and inspections.
• Supports client and regulatory inspections.
• Maintains quality databases and metrics.
• Assists with quality systems, training, vendor management, and inspection readiness.
• Mentors Operations personnel in GMP compliance.

Skills

Aseptic parenteral

Gowning (Grade C)

GMP & Annex 1 experience

Visual inspection qualification

Education

Bachelor’s in Chemistry/Biology/related field

Master’s in related field

Job description

Alcami Corporation is seeking a Senior Quality Assurance Specialist to drive GMP compliance and partner with cross-functional teams in developing SOPs and quality documents. The role emphasizes mentoring Operations personnel and supporting regulatory inspections.

The position requires hands-on quality review, document control, audits, and maintaining quality databases to ensure readiness for inspections and ongoing regulatory compliance.